The Alere NMP22 BladderChek Control Kit consists of a Negative and a Positive Control solution for use as an external control for the Alere NMP22 BladderChek Test.
Alere NMP22 BladderChek Control Kit - D1250
Device Description
A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of nuclear matrix protein 22 in a clinical specimen.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: MMW
Device Name: System, Test, Tumor Marker, Monitoring, Bladder
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: IM
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 866.6010
Third Party Flag: Y
Medical Specialty: IM
Device IdentifiersDevice Id: 10811877010606
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A